Oily wax matrix suspension formulation comprising pharmacologically active agents

Abstract

Embodiments of the present invention relate to an oily wax matrix suspension pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, where the pharmaceutical formulation comprises non-steroidal anti-inflammatory drugs (NSAIDs) including Ketoprofen, Naproxen, and Naproxen Sodium salt form as the active ingredient. The active pharmaceutical ingredient is embedded in an oily matrix, which also comprises a surfactant, a viscosity enhancer and a suspending agent.

What is claimed:  
     
         1 . A pharmaceutical formulation comprising: 
 an active pharmaceutical ingredient embedded into an oily wax matrix;    the oily wax matrix comprising:    a surfactant;    a suspending agent;    a viscosity enhancer;    a dispersion medium; and    a suspension medium,    wherein said formulation is for oral administration, and wherein the active pharmaceutical ingredient is a non-steroidal anti-inflammatory drug (NSAID).    
     
     
         2 . The pharmaceutical formulation of  claim 1 , wherein the formulation is a suspension formulation.  
     
     
         3 . The pharmaceutical formulation of  claim 1 , wherein the surfactant is lecithin.  
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the suspending agent is yellow beeswax.  
     
     
         5 . The pharmaceutical formulation of  claim 1 , wherein the viscosity-imparting agent is partially hydrogenated vegetable oil.  
     
     
         6 . The pharmaceutical formulation of  claim 1 , wherein the dispersion medium is colloidal silicon dioxide.  
     
     
         7 . The pharmaceutical formulation of  claim 1 , wherein the suspension medium is selected from the group consisting of almond oil, babassu oil, borage oil, blackcurrant seed oil, canola oil, castor oil, coconut oil, corn oil, cottonseed oil, evening primrose oil, grape seed oil, groundnut oil, mustard seed oil, olive oil, palm oil, palm kernel oil, peanut oil, rapeseed oil, safflower oil, sesame oil, shark liver oil, sunflower oil, hydrogenated castor oil, hydrogenated coconut oil, hydrogenated palm oil, hydrogenated soybean oil, hydrogenated vegetable oil, hydrogenated cottonseed and castor oil, partially hydrogenated soybean oil, soy oil, glyceryl tricaproate, glyceryl tricaprylate, glyceryl tricaprate, glyceryl triundecanoate, glyceryl trilaurate, glyceryl trioleate, glyceryl trilinoleate, glyceryl trilinolenate, glyceryl tricaprylate/caprate, glyceryl tricaprylate/caprate/laurate, glyceryl tricaprylate/caprate/linoleate, glyceryl tricaprylate/caprate/stearate, saturated polyglycolized glycerides, linoleic glycerides, caprylic/capric glycerides, modified triglycerides, fractionated triglycerides, and mixtures thereof.  
     
     
         8 . The pharmaceutical formulation of  claim 7 , wherein the suspension medium is soybean oil.  
     
     
         9 . The pharmaceutical formulation of  claim 1 , wherein the active pharmaceutical ingredients are non-steroidal anti-inflammatory drugs (NSAIDs).  
     
     
         10 . The pharmaceutical formulation of  claim 9 , wherein the active pharmaceutical ingredients are Ketoprofen, Naproxen or Naproxen Sodium.  
     
     
         11 . A pharmaceutical formulation comprising: 
 about 12.5-75 mg by weight of Ketoprofen;    about 5-20 mg by weight of yellow beeswax;    about 1-15 mg by weight of lecithin, NF;    about 5-25 mg by weight of Partially Hydrogenated Vegetable Oil; and    about 100-500 mg by weight of Soybean Oil, USP,    wherein said formulation is for oral administration.    
     
     
         12 . The pharmaceutical formulation of  claim 11 , further comprising about 1-15 mg by weight of Colloidal silicon dioxide and wherein the amount of Soybean Oil, USP is about 100-300 mg by weight.  
     
     
         13 . A method for preparing a pharmaceutical formulation comprising: 
 preparing an oily matrix consisting of soybean oil, beeswax and partially hydrogenated vegetable oil;    blending lecithin and silicon dioxide to said oily matrix;    mixing an active pharmaceutical ingredient into the said matrix; and    encapsulating the oily matrix-embedded pharmaceutical complex into a capsule for oral administration.    
     
     
         14 . The method for preparing the pharmaceutical formulation of  claim 13 , wherein the said active pharmaceutical ingredient is Ketoprofen.  
     
     
         15 . The method for preparing the pharmaceutical formulation of  claim 13 , wherein the said capsule is a soft gelatin capsule.  
     
     
         16 . A pharmaceutical formulation for oral administration comprising: 
 an active ingredient of Naproxen, in an amount by weight selected from the group consisting of about 250 mg, about 375 mg, and about 500 mg by weight, or of Naproxen Sodium, in an amount by weight selected from the group consisting of about 220 mg, about 275 mg, and about 550 mg;    yellow beeswax, in about 1-0.30 mg of weight;    lecithin, in about 5-50 mg by weight; and    soybean oil, in about 100-500 mg by weight.    
     
     
         17 . The pharmaceutical formulation of  claim 16 , wherein 
 the active ingredient is selected from the group consisting of Naproxen, in an amount by weight of 250 mg, Naproxen in an amount by weight of about 375 mg, Naproxen Sodium in an amount of by weight of about 220 mg, and Naproxen Sodium in an amount by weight of about 275 mg;    the yellow beeswax is in an amount by weight of about 1-15 mg; and    the amount of lecithin is in an amount by weight of about 5-35.    
     
     
         18 . The pharmaceutical formulation of  claim 17 , wherein the active ingredient is Naproxen.  
     
     
         19 . The pharmaceutical formulation of  claim 17 , wherein the active ingredient is Naproxen Sodium.  
     
     
         20 . The pharmaceutical formulation of  claim 16 , wherein the active ingredient is Naproxen in an amount by weight of about 500 mg or Naproxen Sodium in an amount by weight of about 550 mg.  
     
     
         21 . The phamaceutical formulation of  claim 20 , wherein the active ingredient is Naproxen.  
     
     
         22 . The pharmaceutical formulation of  claim 20 , wherein the active ingredient is Naproxen Sodium.  
     
     
         23 . A method for preparing a pharmaceutical formulation consisting of: 
 preparing an oily matrix consisting of soybean oil and beeswax;    blending lecithin to said oily matrix;    mixing an active pharmaceutical ingredient into the said matrix; and    encapsulating the oily matrix-embedded pharmaceutical complex into a capsule.    
     
     
         24 . The method of  claim 23 , wherein the said active pharmaceutical ingredient is Naproxen or Naproxen Sodium.  
     
     
         25 . The method of  claim 23 , wherein the said capsule is a soft gelatin capsule.